IRX-2, and Pembrolizumab in Treating Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Cancer
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|ClinicalTrials.gov Identifier: NCT03918499|
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Gastric Adenocarcinoma Stage IV Gastroesophageal Junction Adenocarcinoma||Drug: IRX-2 Biological: Pembrolizumab||Phase 1 Phase 2|
I. To determine the safety profile of combination IRX-2 regimen and pembrolizumab.
I. To evaluate the overall response rate of IRX-2 regimen combined with pembrolizumab using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune modified RECIST criteria.
II. To evaluate initial median progression-free and overall survival in these patients treated with combination IRX-2 regimen and pembrolizumab.
I. To evaluate the circulating T cell profiles in patients before and after therapy with combination IRX-2 regimen and pembrolizumab.
II. To evaluate the baseline and post-treatment tumor tissue immune gene expression profiling using the Nanostring platform.
III. To explore identification of tumor tissue neoantigens through a multiplex proteomic assay (MHC-PepSeq) paired with tumor genomic and transcriptomic sequencing.
IV. To explore putative biomarkers (including circulating tumor deoxyribonucleic acid [DNA] and immune cell profiles) in peripheral blood to generate hypotheses for response to treatment with combination IRX-2 regimen and pembrolizumab.
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Participants also receive cyclophosphamide IV on day 1 and IRX-2 subcutaneously (SC) on for 10 days starting on day 4 during courses 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease or unacceptable toxicity.
After completion of study treatment, participants are followed up for 30 days and then up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Trial of the IRX-2 Regimen and Pembrolizumab in Patients With Advanced Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma|
|Actual Study Start Date :||April 18, 2019|
|Estimated Primary Completion Date :||June 24, 2021|
|Estimated Study Completion Date :||June 24, 2021|
Experimental: IRX-2 Regimen combined with Pembrolizumab
IRX-2 Regimen (2 mL - Dose level 1, 4 mL - Dose level 2) combined with Pembrolizumab (200 mg)
IRX-Regimen: 21 day regimen of cyclophosphamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 15. This 21 day regimen will be given every 12 weeks
Pembrolizumab 200 mg will be given via IV infusion once every 21 days
- Number of participants with dose-limiting toxicities as assessed by CTCAE v5.0 [ Time Frame: Up to 30 days after last dose ]
- Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and immune related (ir)RECIST [ Time Frame: From first day of study drug administration to disease progression or death, assessed up to 2 years ]Kaplan-Meier estimates and corresponding 95% confidence intervals for the median and quartiles will be provided.
- Overall survival assessed by RECIST 1.1 criteria and irRECIST [ Time Frame: Up to 2 years ]
- Overall response rate assessed by RECIST 1.1 criteria and irRECIST [ Time Frame: Up to 2 years ]
- Circulating T cell profiles for each participant with the combination of IRX-2 regimen and pembrolizumab [ Time Frame: At pre- and post-intervention assessed up to 2 years ]Will be compiled using descriptive statistics. Data will be screened for parametric statistical assumption and the alpha level for all statistical tests will be set at .05. The Bonferroni correction will be applied to adjust for potentially inflated family wise error rates for multiple comparisons with the same sample.
- Difference in tumor tissue Nanostring expression profiling [ Time Frame: From baseline to post-treatment assessed up to 2 years ]Will conduct repeated measures t-tests. Data will be screened for parametric statistical assumption and the alpha level for all statistical tests will be set at .05. The Bonferroni correction will be applied to adjust for potentially inflated family wise error rates for multiple comparisons with the same sample.
- Identification of tumor neoantigens using multiplex proteomic assay (MCH-PepSeq) assay [ Time Frame: Up to 2 years ]
- Circulating tumor deoxyribonucleic acid (DNA) detection from peripheral blood as an exploratory pharmacodynamic biomarker of response [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918499
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Joseph Chao, MD 626-218-3494 firstname.lastname@example.org|
|Principal Investigator: Joseph Chao, MD|
|United States, Texas|
|Texas Oncology at Baylor Charles A Sammons Cancer Center||Not yet recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Andrew S. Paulson 214-370-1000 email@example.com|
|Principal Investigator: Andrew S. Paulson|
|Principal Investigator:||Joseph Chao, MD||City of Hope Medical Center|